On January 28, 2020, we will release our sixth webinar, Enrichment Trials. This topic will be presented by Dr. Kert Viele of Berry Consultants, LLC. Details are below for joining the live broadcast. The recording will also be made available at this page as soon as possible after the broadcast. Register for a free account to receive notices when new content is posted!
When: Jan 28, 2020 02:00 PM Central Time (US and Canada)
Topic: ICTR Webinar #6 Enrichment
Please click the link below to join the webinar:
Or iPhone one-tap :
US: +16465588656,,146186146# or +17207072699,,146186146#
Dial(for higher quality, dial a number based on your current location):
US: +1 646 558 8656 or +1 720 707 2699
Webinar ID: 146 186 146
International numbers available: https://zoom.us/u/am9OxW9AZ
Very few therapies benefit everyone. When we have uncertainty about “who benefits?”, a standard “one size fits all” clinical trial will fail. If, for example, half the population benefits and the other half does not, then any overall conclusion will miss half the population. If the trial is successful, we may mistakenly give the treatment to the poorly treated half. If the trial is unsuccessful, often this is because of the dilution of the treatment effect from the poorly treated half. Post-hoc subgroup analyses attack this problem, but are typically underpowered and prone to multiplicity issues.
Enrichment trials prospectively investigate subgroups. During the trial, we estimate the effect of our therapy in each subgroup, and adaptively drop subgroups that are performing poorly, allowing for greater sample sizes in the remaining subgroups. These greater sample sizes allow for increased power in the presence of differential subgroup effects. We will review these methodologies, discuss their benefits and risks (for example, they are typically larger than a standard trial), and provide examples from the literature.